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Non Small Cell Lung CancerPhase 1NCT03306680

SUNSET: SBRT for Ultra-central NSCLC- a Safety and Efficacy Trial

A Phase 1 study testing SBRT in people with Non Small Cell Lung Cancer, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 7 sites in Canada.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This multi-centre phase I dose-escalation study will use a time-to-event continual reassessment method (TIT-CRM). Accrual will start at level 1 (60 Gy in 8 fractions). Patients will be assigned to treatment doses using the TITE-CRM model. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non Small Cell Lung Cancer
What is being tested?
SBRT
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
7 sitesCanada
Study dates
19 Jan 2018to Sep 2026
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Pathologically (histologically or cytologically) proven diagnosis of non-small cell lung cancer (NSCLC); if the risk of biopsy is unacceptable, pathologic confirmation is not required providing there is serial growth on serial (>=2) CT imaging and/or FDG avidity that is strongly suggestive of a primary NSCLC.
  • Stage T1-3, N0, M0 (UICC/AJCC Staging, 8th Ed.), tumor size < 6 cm, prior to registration, based upon the following minimum diagnostic workup:
  • History/physical examination within 4 weeks prior to registration
  • CT scan with contrast (unless medically contraindicated) within 12 weeks of registration. The CT scan will include the entirety of both lungs, the mediastinum, liver and adrenal glands; the primary tumor dimensions will be measured on CT. Note: Patients with lesions that cannot be visualized by CT scan are not eligible for the study.
  • Whole body positron emission tomography (PET) scan within 12 weeks of registration, using FDG with adequate visualization of the primary tumor and draining lymph node basins in the hilar and mediastinal regions.
  • Mediastinal lymph node sampling by any technique is encouraged but not required. Patients with hilar or mediastinal lymph nodes <1 cm and no abnormal hilar or mediastinal uptake on PET will be considered N0. Patients with > 1 cm hilar or mediastinal lymph nodes on CT or abnormal PET (including suspicious but nondiagnostic uptake) may still be eligible if directed tissue biopsies of all abnormally identified areas are negative for cancer.
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  • ECOG performance status 0-2;
  • age >18;
  • Ultra-central tumor location: tumours whose planning target volume (PTV) is expected to touch or overlaps the central bronchial tree, esophagus, pulmonary vein, or pulmonary artery as determined at the time of consultation.

Who cannot join

  • Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 2 years (e.g. carcinomas in situ of the breast, oral cavity, or cervix are permissible); previous lung cancer, if the patient is disease-free for a minimum of 2 years is permitted.
  • Any prior thoracic radiotherapy.
  • Any prior chemotherapy for the study cancer (cancer proposed to be treated on the study).
  • Prior surgery for the study cancer.
  • Plans for the patient to receive other local therapy (including standard fractionated radiotherapy and/or surgery) while on this study, except at disease progression;
  • Plans for the patient to receive systemic therapy (including standard chemotherapy or biologic targeted agents), while on this study, except at disease progression.
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  • Pregnancy.
  • The following autoimmune and connective tissue diseases will be excluded: Scleroderma and Systemic lupus erythematosus
  • patients with interstitial lung disease (ILD).

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

Canada7 sites

  • London Regional Cancer Program

    London, Ontario, N6A 4L6

  • Centre Hospitalier de l'Universite de Montreal (CHUM)

    Montreal, Quebec, H2X 0A9

  • McGill University Health Centre-Cedars Cancer Centre

    Montreal, Quebec, H4A 3J1

  • Saskatoon Cancer Centre

    Saskatoon, Saskatchewan, S7S 0B1

  • Sunnybrook Odette Cancer Centre

    Toronto, Ontario, M4N 3M5

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 1X6

  • BC Cancer -Vancouver Island

    Vancouver, British Columbia, V8R 6V5

Other trials in Canada

About this study

This multi-centre phase I dose-escalation study will use a time-to-event continual reassessment method (TIT-CRM).

Accrual will start at level 1 (60 Gy in 8 fractions). Patients will be assigned to treatment doses using the TITE-CRM model. The model will use all available information from previously accrued patients to assign the highest dose with a predicted risk of grade 3 toxicity of 30% or less.

Read the detailed description

This study will use a time-to-event continual reassessment method (TITE-CRM). The study design is based on RTOG 0813 (described above), but with a more cautious approach, since the patients herein may constitute a high-risk subset of the patients enrolled in RTOG 0813. The modifications include a starting dose (60 Gy in 8 fractions) herein that is lower than the safe dose for central tumors as determined by RTOG 0813 (60 Gy in 5 fractions), and longer follow-up period during which patients are considered at-risk for toxicity, (i.e. two years herein vs. one year in RTOG 0813).

The primary endpoint of this study is the maximally tolerated dose (MTD) of radiotherapy for ultracentral tumors. The MTD is the dose of radiotherapy associated with a <30% rate of grade 3-5 toxicity occurring within 2 years of treatment.

Local Progression, Regional nodal progression, Distant metastases, Progression-Free Survival, Overall survival, patient reported outcomes and quality of life.

The correlative objectives of this study are to determine the prognostic value of ctDNA levels measured pre-treatment, at the end of treatment and 3- and 12-months after treatment.

Being tested
SBRT
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SBRTRadiation

    Patients will be assigned to treatment doses using the TITE-CRM model.

Study groups in NCT03306680
Study groupRoleWhat they receive
Patients with ultra-central NSCLC T1-3 (<6cm) N0 M0ExperimentalLevel-1 Dose per fraction: 4Gy Number of fractions: 15 Total Dose: 60 Gy Level 0 Dose per fraction: 6Gy Number of fractions: 10 Total Dose: 60 Gy Level 1 Dose per fraction: 7.5 Gy Number of fractions: 8 Total Dose: 60 Gy
Receives: Radiation: SBRT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximally tolerated dose (MTD)

    MTD of radiotherapy for ultracentral tumors. The MTD is the dose of radiotherapy associated with a <30% rate of grade 3-5 toxicity occurring within 2 years of treatment.

    Measured: Occurring within 2 years of treatment

Secondary outcomes (7)

  1. Time to Local Progression

    Measured: 3-5 years

  2. Regional nodal progression

    Defined as presence of enlarged lymph nodes >1 cm [short axis] in the hilum or mediastinum.

    Measured: 3-5 years

  3. Time to distant metastases

    Measured: 3-5 years

  4. Progression-Free Survival

    Measured: 3-5 years

  5. Overall survival

    Measured: 3-5 years

  6. Patient reported outcome

    FACT-L

    Measured: Before treatment & at 3, 6, 9, 12, 18, 24, 36, 48, and 60 months

  7. Quality of Life

    EQ-5D-5L

    Measured: Before treatment & at 3, 6, 9, 12, 18, 24, 36, 48, and 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Oct 2017
  2. Study start19 Jan 2018
  3. Primary completion19 Apr 2021
  4. Study completionSep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03306680
Sponsor's protocol ID
SUNSET
Status last verified
Sep 2025
First submitted
28 Sep 2017
Last updated
18 Sep 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Giuliani ME, Filion E, Faria S, Kundapur V, Toni Vu TTT, Lok BH, Raman S, Bahig H, Laba JM, Lang P, Louie AV, Hope A, Rodrigues GB, Bezjak A, Campeau MP, Duclos M, Bratman S, Swaminath A, Salunkhe R, Warner A, Palma DA. Stereotactic Radiation for Ultra-Central Non-Small Cell Lung Cancer: A Safety and Efficacy Trial (SUNSET). Int J Radiat Oncol Biol Phys. 2024 Nov 1;120(3):669-677. doi: 10.1016/j.ijrobp.2024.03.050. Epub 2024 Apr 12.

    PubMed 38614279

  • Rosenberg SA, Mak R, Kotecha R, Loo BW Jr, Senan S. The Nordic-HILUS Trial: Ultracentral Lung Stereotactic Ablative Radiotherapy and a Narrow Therapeutic Window. J Thorac Oncol. 2021 Oct;16(10):e79-e80. doi: 10.1016/j.jtho.2021.06.030. No abstract available.

    PubMed 34561039

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SBRT in people with Non Small Cell Lung Cancer, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 7 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximally tolerated dose (MTD) (time frame: Occurring within 2 years of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03306680, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025.

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